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A Phase I Dose Escalation Study With Sunitinib (SutentR) in Combination With Capecitabine and Irinotecan (Capiri) in Previously Treated Patients With Advanced Colorectal Cancer

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Phase I Dose Escalation Study With Sunitinib (SutentR) in Combination With Capecitabine and Irinotecan (Capiri) in Previously Treated Patients With Advanced Colorectal Cancer

Inclusion Criteria:

- Histological proof of colorectal cancer

- Patients should have failed one previous line of systemic treatment for advanced
disease (and not more than one treatment line), either with fluoropyrimidine
monotherapy or in combination with oxaliplatin and/or bevacizumab.

- No prior treatment with irinotecan or sunitinib

- Age ≥ 18 years

- WHO PS 0-1 (see Appendix 3, corresponding with Karnofsky ≥ 70% )

- Life expectancy ≥ 12 weeks

- Written informed consent

Exclusion Criteria:

- No measurable disease according to RECIST criteria.

- Prior anti-cancer therapy < 3 weeks before first dose. For cetuximab < 30 days or
bevacizumab < 60 days prior to the first dose.

- Unresolved toxicity > CTC gr 1 from previous anti-cancer therapy (including
radiotherapy) except for alopecia.

- Inadequate bone marrow function (Hb ≤ 5.6 mmol/L, absolute neutrophil count (ANC) ≤
1.5 x 109/L, platelets ≤100 x 109/L)

- renal dysfunction (serum creatinine ≥ 1.5x ULN and glomerular filtration rate ≤ 50

- Prothrombin time (PT) and activated partial thromboplastin time (APTT) > 2x ULRR

- Hepatic dysfunction (serum bilirubin ≥ 1.5x ULN, serum transaminases ≥ 2.5 x ULN)

- Greater than +1 proteinuria on two consecutive dipsticks taken no less then 2 weeks
apart unless urinary protein < 1,5 g in a 24 Hr period.

- Pregnant or lactating women

- History of clinical signs/symptoms of CNS metastases

- Previous intolerance of fluoropyrimidine therapy, known dihydropyrimidine
dehydrogenase (DPD) deficiency. Known hypersensitivity to irinotecan or sunitinib of
their excipients.

- No major surgery < 4 weeks prior to study entry.

- No radiotherapy < 4 weeks prior to study entry except for palliative radiotherapy at
focal sites.

- Any evidence of concurrent severe or uncontrolled disease (i.e. uncontrolled
hypertension, congestive heart failure, myocardial infarction < 6 months, chronic
active infection, poorly regulated diabetes mellitus)

- Any previous significant cardiovascular event during previous fluoropyrimidine
therapy (i.e.

myocardial ischemia or infarction, arterial thrombosis, pulmonary emboli)

- Mean Qtc with Bazetts correction > 470 msec in screening ECG, or a history with
familial long QT syndrome

- Significant haemorrhage (>30 ml bleeding/episode in the last 3 months) or haemoptysis
(>5 ml fresh blood in previous 4 weeks)

- History of impairment of gastrointestinal function or -disease that may significantly
impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea,
malabsorption syndrome, bowel obstruction, or inability to swallow tablets)

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be discussed with the patient before registration in the trial

- Concomitant use medication that may significantly affect hepatic cytochrome P450 drug
metabolizing activity by way of enzyme induction or inhibition < 2 weeks if the first
dose and throughout the study period (see Appendix 2)

- Other concomitant anti-cancer therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

after every completed doselevel

Safety Issue:


Principal Investigator

C.M.L. van Herpen, MD, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMCN st Radboud


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2008

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • Sunitinib
  • Capecitabine
  • Irinotecan
  • colorectal cancer
  • Colorectal Neoplasms